Inpatient and Outpatient Balloon Catheter Cervical Ripening

A Comparison Between Inpatient and Outpatient Balloon Catheter Cervical Ripening: A Prospective Randomized Controlled Trial

A randomised controlled trial comparing cervical ripening using foley catheter as in- or outpatient setting.

Study Overview

• Status: Completed
• Conditions: Caesarean Section; Infection
• Intervention / Treatment: Device: Foley catheter cervical ripening

Detailed Description

The study evaluated the efficacy and safety of outpatient versus inpatient Foley catheter cervical ripening and patients' satisfaction. Sixty low-risk women were randomized to outpatient and inpatient management of intracervical Foley catheter digital insertion. The outpatient group was provided with verbal and written 24-hours contact information and instructions. Both groups were reassessed the next morning unless labor had begun or the catheter had dropped off.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • UKM Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• singleton
• gestational age beyond 37 weeks
• cephalic presentation
• intact membranes
• Bishop score less than 6
• lives within 10km from National University Malaysia Medical Centre or able to reach within 30 minutes
• readily available transport

Exclusion Criteria:

• intrauterine death
• intrauterine fetal growth restriction
• estimated fetal weight more than 4000gram
• fetal anomalies
• abnormal pre-induction cardiotocograph
• non-vertex presentation
• unstable lie
• sepsis
• hypertension
• allergy to latex
• previous uterine scar
• history of antepartum haemorrhage
• parity of 6 and more
• placenta praevia
• suspected cephalopelvic disproportion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Foley catheter inpatient; Participants had intracervical ripening with foley catheter after admission into the ward.	Device: Foley catheter cervical ripening; Participants were assessed when labour was established or the following morning.
Active Comparator: Foley catheter outpatient; Participants had intracervical ripening with foley catheter and allowed home.	Device: Foley catheter cervical ripening; Participants were assessed when labour was established or the following morning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caesarean section rate	Percentage of Caesarean section	From the time of recruitment until delivery
Neonatal sepsis	Percentage of neonates with sepsis	From birth up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal age	Mean maternal age in years	At the time of recruitment
Ethnicity	Percentage of each races	At the time of recruitment
Education level	Percentage of participants with secondary or higher education level	At the time of recruitment
Occupation	Percentage of participants who were professional or non professional or housewives	At the time of recruitment
Pre-pregnancy maternal body mass index	Mean pre-pregnancy body mass index in kg/m2	At the time of recruitment
Parity	Percentage of participants who are nulliparous or multiparous	At the time of recruitment
Gestation at recruitment	Percentage of participants who were recruited at 40 or 40 weeks and 10 days	At the time of recruitment
Indication	Percentage of participants who were induced based on indication	At the time of recruitment
Bishop score pre-induction	Mean Bishop score prior to induction. Unfavourable score has minimum score of 0 and maximum score of 5.	Pre-intervention
Bishop score at second assessment	Mean Bishop score at second assessment. Unfavourable score has minimum score of 0 and maximum score of 5.	From insertion of Foley catheter until labour established or the following morning
Management at second assessment	Percentage of participants who had dinoprostone insertion or artificial rupture of membranes	At time of recruitment until delivery
Duration from induction until favourable Bishop score	Mean duration taken from induction until favourable Bishop score in hours	At time of recruitment until delivery
Augmentation with oxytocin	Percentage of participants who required oxytocin augmentation	At time of recruitment until delivery
Duration of oxytocin use	Mean duration of oxytocin use in minutes	At time of recruitment until delivery
Duration from amniotomy until delivery	Mean duration from amniotomy until delivery in hours	At time of recruitment until delivery
Duration from induction until delivery	Mean duration from induction until delivery in hours	At time of recruitment until delivery
Delivery within 24 hours	Percentage of participants who delivered within 24 hours from induction	At time of recruitment until delivery
Duration of inpatient stay	Mean duration of inpatient stay in hours	At time of recruitment until delivery
Total blood loss	Median blood loss in millilitres	At the time of delivery
Intrapartum pyrexia	Percentage of participants with intrapartum pyrexia	At the time of delivery
Primary postpartum haemorrhage	Percentage of participants with primary postpartum haemorrhage	Immediately at delivery up to 42 days
Birth weight	Mean birth weight in grams	At the time of delivery
Arterial cord blood acidity or alkalinity	Mean arterial cord blood acidity or alkalinity	At the time of delivery
Neonatal white cell count	Mean neonatal white cell count in liter	At the time of delivery
Neonatal C-reactive protein	Median neonatal C-reactive protein in milligram per liter	At the time of delivery
Discomfort with foley catheter	Percentage of participants experienced discomfort with foley catheter	At the time of recruitment until active phase of labour
Ability to cope with discomfort	Percentage of participants able to cope with discomfort	At the time of recruitment until active phase of labour
Intention to use the method again	Percentage of participants who intend to use similar method in future	Through study completion until delivery
Feeling alone during induction	Percentage of participants who felt lonely during induction	At the time of recruitment until delivery
Duration of sleep	Duration of sleep during induction in hours	At the time of recruitment until delivery
Able to rest and relax	Percentage of participants who are able to rest and relax	At the time of recruitment until delivery
Feeling of unsafe during cervical ripening	Percentage of participants who felt unsafe during cervical ripening	At the time of recruitment until active phase of labour
Embarrassed by the method	Percentage of participants who felt embarrassed by the method	At the time of recruitment until active phase of labour

Collaborators and Investigators

• Sponsor: National University of Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Patient satisfaction; cervical ripening; Foley catheter
• Other Study ID Numbers: FF-2017-358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No